Lebrikizumab Delivers Strong 16-Week Results in Atopic Dermatitis

Lebrikizumab is effective and safe as a treatment for atopic dermatitis over the course of 16 weeks, according to recent findings.1

These findings resulted from an analysis of the BIOREP registry, with such study authors as Filip Rob, MD, PhD, from the Department of Dermatovenereology at Bulovka University Hospital in Prague, Czech Republic. Rob et al highlighted prior research into lebrikizumab’s use among those living with this inflammatory skin disease.

“Lebrikizumab, an anti-interleukin-13 antibody for atopic dermatitis (AD), has shown efficacy and safety in clinical trials, but real-world data remain limited,” Rob and coauthors wrote.1,2 “This analysis evaluates its effectiveness and safety over 24 weeks in patients from the Czech BIOREP registry.”

Trial Design

The investigative team looked specifically at patients with moderate-to-severe atopic dermatitis. These study subjects initiated lebrikizumab therapy between September - December 2024. Among the 181 Rob and colleagues originally identified, 171 completed at least a single follow-up visit at the 16-week mark, and 46.4% of the participants returned for a second follow-up interaction at the 24-week mark.

Several subgroups were also evaluated by the team, including a treatment-naïve cohort [n=105, baseline mean Eczema Area and Severity Index (EASI) 29.8, SD ±8.3]. They also assessed a cohort of individuals with prior dupilumab failure, including both primary and secondary non-responders (n=35, baseline mean EASI 24.5, SD ±11.0; mean prior dupilumab duration 17 months, range 4–56). Additionally, Rob and coauthors highlighted subjects who had failed JAK inhibitors previously (n=44, baseline mean EASI 27.5, SD ±9.5).

In terms of itch outcomes, only individuals with baseline Itch NRS ≥4 were assessed by the investigative team for clinically meaningful reductions of ≥4 points. The team also permitted the background utilization of emollients and other topical treatments throughout their study period.

Findings on Lebrikizumab for Atopic Dermatitis

63.7% of the 171 individuals assessed by Rob and colleagues at 16 weeks were able to attain an EASI-75 response. These rates were noted by the investigators to be significantly higher in the treatment-naïve cohort as opposed to those labeled as prior dupilumab non-responders, with 69.5% versus 48.6%, respectively (P < .05). Such responses were also found to be numerically higher, though not statistically significant, compared with those with JAK inhibitor failure, at 69.5% compared to 54.5%, respectively (P = .09).

An EASI-90 response to lebrikizumab use at the 16-week mark was achieved by 34.5% of all trial subjects. Those deemed as treatment-naïve were found to have higher response rates than those who had failed dupilumab previously, with a rate of 41.9% versus 22.9%, respectively (P < .05). When Rob et al looked at itch improvements at Week 16, 51.6% attained a ≥4-point reduction in Itch NRS.

Such a response occurred more commonly among treatment-naïve individuals versus those with dupilumab failures (60.0% versus 26.7%, P < .01), with a numerical advantage—though not statistically significant—over those who failed JAK inhibitors (60.0% versus 43.9%, P = .09). In the investigative team's safety analysis, 13.8% of participants noted having at least a single treatment-emergent adverse event (TEAE) during the period in which they were assessed. However, none of these were classified as serious.

Conjunctivitis was the most commonly-reported AE, occurring in 10.5% of patients, and Rob and coauthors concluded that no other individual TEAE took place in more than 2% of participants. There were 14 subjects (7.7%) who decided to discontinue lebrikizumab in this period, with 5 citing a lack of efficacy, 7 citing TEAEs, and 2 being due to patient request. By the 24-week follow-up, among 84 patients, an additional 4 discontinued the medication because of insufficient efficacy.

“Preliminary findings from the initial 16-week analysis, based on a small sample size, could suggest a considerable reduction in efficacy among patients who have previously experienced dupilumab treatment failure, compared to naïve ones,” the investigators concluded.1

References

1. Rob F, Gkalpakiotis S, Kojanová M, et al. Efficacy and safety of lebrikizumab in atopic dermatitis over 24 weeks: An analysis from the BIOREP registry. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.70009.

2. Paller AS, Flohr C, Soung J, et al. Safety and efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: a 52-week, open-label, phase 3 study. Dermatol Ther (Heidelb). 2023; 13: 1517–1534.